Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 11:52 AM
Study NCT ID:
NCT00454766
Status:
UNKNOWN
Last Update Posted:
2020-12-30
First Post:
2007-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Materials to Educate Patients About Cervical Dysplasia
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Evaluating Materials to Educate Patients About Cervical Dysplasia
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
To pilot test high and low literacy patient education materials for colposcopy clinic patients, assessing impact on patient knowledge and patient feedback about the materials.
To pilot test high and low literacy patient education materials for colposcopy clinic patients, assessing impact on patient knowledge and patient feedback about the materials.
Detailed Description:
Women with an abnormal Papanicolaou (Pap) smear are typically referred for a colposcopy and biopsy. However, data collected by research groups and others shows that women with abnormal Pap smear results have limited understanding of the meaning of the results, the causes of cervical dysplasia, and the procedures used to evaluate and treat it. This situation is further complicated by the fact that many patients, particularly those with less education, have low health literacy in general. This means that much of the existing patient education materials will likely be inappropriate or ineffective for this group. One approach is to develop materials at low literacy levels; however, it is not known whether such materials will be provide sufficient information and be effective for patients with high health literacy.
The long term goal is to study the importance of tailoring patient education materials to colposcopy patients' level of health literacy. To this end, researchers have developed two educational brochures with approximately the same information, but which vary in their health literacy (readability) level. As a first step in this research, researchers propose to present these materials to colposcopy patients returning for colposcopy visits to assess changes in knowledge and obtain patient feedback on the brochures.
The proposed pilot study represents the first step at evaluating the patient education materials and determining the patient's level of understanding of what they receive.
The long term goal is to study the importance of tailoring patient education materials to colposcopy patients' level of health literacy. To this end, researchers have developed two educational brochures with approximately the same information, but which vary in their health literacy (readability) level. As a first step in this research, researchers propose to present these materials to colposcopy patients returning for colposcopy visits to assess changes in knowledge and obtain patient feedback on the brochures.
The proposed pilot study represents the first step at evaluating the patient education materials and determining the patient's level of understanding of what they receive.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: